Clinical Trials for Cancer Patients: Is Participation Linked to Better Health Outcomes?
There is a widely held belief in the oncology community that patients with cancer who enroll in clinical trials generally experience better health outcomes than patients with cancer who do not enroll in clinical trials. Indeed, this belief is so widespread, that the American Federation of Clinical Oncologic Societies (AFCOS) claims that “treatment in a clinical trial is often a cancer patient’s best option.” Still other organizations claim that clinical trials offer children with cancer the best hope of survival and that access to clinical trials is a basic requirement of quality cancer care. One risk of these claims is that cancer patients may come to believe that clinical trials are not only desirable but a necessary part of their treatment.
But, is there evidence to support this widespread assumption? Recently, a group of researchers set out to assess the medical evidence that such an effect, called a trial effect, really exists. The results of their study were published in the January issue of The Lancet. The researchers found that there was little clinical data to support the belief that enrolling cancer patients in clinical trials results in better outcomes for these patients.
About the study
Through a comprehensive search of the medical literature, the researchers identified clinical studies that compared the outcomes of cancer patients who were enrolled in clinical studies with cancer patients who were not enrolled in clinical studies. They evaluated these studies to determine whether there was evidence to support the claim of a positive trial effect for cancer patients.
The researchers identified a total of 24 relevant studies. Of these, only 14 suggested cancer patients in clinical studies had better outcomes than cancer patients not enrolled in clinical studies. However, most of these studies did not adequately control for bias (the tendency to introduce error into a measurement by favoring one answer, outcome, or value over others). Indeed, only nine of the studies met the minimum requirement of recording the same information for all subjects, irrespective of whether they were in a clinical trial or not. In the end, the researchers found only three well-designed studies that determined trial participants had better outcomes than non-participants.
How does this affect you?
In the final analysis, the researchers concluded that there is little evidence to support the claim that cancer patients who enroll in clinical trials are significantly better off than those who do not. They go on to say that until there is more convincing data that a positive trial effect really does exist, physicians attempting to recruit cancer patients into clinical trials should urge them to participate because of the important role such trials play in the treatment of future patients.
If you are a cancer patient and are considering enrolling in a clinical trial, ask your doctor to talk with you realistically about what type of trial it is and what benefits you can reasonably expect. And when making your decision, be sure to consider the many patients before you who participated in the trials from which you may benefit. While there remains some question as to whether your own participation in a trial will improve your outlook, there is little question it will benefit cancer patients as a whole.
American Cancer Society
Clinicaltrials.gov: A service of the National Institutes of Health
National Cancer Institute
Peppercorn JM, Weeks JC, Cook EF et al. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004; 363:263-270.
Last reviewed Jan 30, 2004 by ]]>Richard Glickman-Simon, MD]]>
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